Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary)

FDA 510(k) K081345 · Thermogenesis Corp.

Substantially Equivalent for Some Indications

510(k) numberK081345

Submission

Device name
Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary)
Applicant
Thermogenesis Corp.
Rancho Cordova, CA, US
Received
May 14, 2008
Decision date
July 10, 2008
Decision
Substantially Equivalent for Some Indications (SN)
Type
Abbreviated 510(k)

Official FDA 510(k) record

Device classification

Product code
JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2050
Specialty
Clinical Chemistry

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Questions and answers

When was Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary) cleared by the FDA?

Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary) (K081345) received a 510(k) decision of Substantially Equivalent for Some Indications on July 10, 2008, 57 days after the submission was received.

What is the product code of K081345?

The FDA product code is JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2050.